title: AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance.
abstract: All-trans-retinoic acid (ATRA) has greatly modified the prognosis of acute promyelocytic leukemia; however, the role of maintenance in patients in molecular complete remission after consolidation treatment is still debated. From July 1993 to May 2000, 807 genetically proven newly diagnosed acute promyelocytic leukemia patients received ATRA plus idarubicin as induction, followed by 3 intensive consolidation courses. Thereafter, patients reverse-transcribed polymerase chain reaction-negative for the PML-RARA fusion gene were randomized into 4 arms: oral 6-mercaptopurine and intramuscular methotrexate (arm 1); ATRA alone (arm 2); 3 months of arm1 alternating to 15 days of arm 2 (arm 3); and no further therapy (arm 4). Starting from February 1997, randomization was limited to ATRA-containing arms only (arms 2 and 3). Complete remission was achieved in 761 of 807 (94.3%) patients, and 681 completed the consolidation program. Of these, 664 (97.5%) were evaluated for the PML-RARA fusion gene, and 586 of 646 (90.7%) who tested reverse-transcribed polymerase chain reaction-negative were randomized to maintenance. The event-free survival estimate at 12 years was 68.9% (95% confidence interval, 66.4%-71.4%), and no differences in disease-free survival at 12 years were observed among the maintenance arms.
authors.affiliation: Unità Operativa Complessa di Ematologia e Terapia Cellulare, Università Campus Bio-Medico, Roma, Italy. g.avvisati@unicampus.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Avvisati
authors.forename: Francesco
authors.initials: F
authors.lastname: Lo-Coco
authors.forename: Francesca Paola
authors.initials: FP
authors.lastname: Paoloni
authors.forename: Maria Concetta
authors.initials: MC
authors.lastname: Petti
authors.forename: Daniela
authors.initials: D
authors.lastname: Diverio
authors.forename: Marco
authors.initials: M
authors.lastname: Vignetti
authors.forename: Roberto
authors.initials: R
authors.lastname: Latagliata
authors.forename: Giorgina
authors.initials: G
authors.lastname: Specchia
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Eros
authors.initials: E
authors.lastname: Di Bona
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fioritoni
authors.forename: Filippo
authors.initials: F
authors.lastname: Marmont
authors.forename: Alessandro
authors.initials: A
authors.lastname: Rambaldi
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Kropp
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pizzolo
authors.forename: Enrico M
authors.initials: EM
authors.lastname: Pogliani
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rossi
authors.forename: Nicola
authors.initials: N
authors.lastname: Cantore
authors.forename: Francesco
authors.initials: F
authors.lastname: Nobile
authors.forename: Attilio
authors.initials: A
authors.lastname: Gabbas
authors.forename: Felicetto
authors.initials: F
authors.lastname: Ferrara
authors.forename: Paola
authors.initials: P
authors.lastname: Fazi
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007223:Infant; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D008875:Middle Aged; D015514:Oncogene Proteins, Fusion / Q000235:genetics; D012074:Remission Induction; D014212:Tretinoin / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D015514:Oncogene Proteins, Fusion; C093476:promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein; D014212:Tretinoin; D015255:Idarubicin